Medical fluid therapy machine including servicing regime therefore

ABSTRACT

A medical fluid delivery system includes: a medical fluid delivery machine including a component having at least one of associated output data or associated test data; at least one of a (i) component output replacement limit and a component output soft limit for the component or (ii) a component testing replacement limit or a component testing soft limit for the component; and a computer programmed to store at least one of (i) or (ii), and for (i) analyze the output data to provide a first indication of how well the component is performing relative to the component output replacement limit and the component output soft limit, and for (ii) analyze the test data to provide a second indication of how well the at least one component is testing relative to the component testing replacement limit and the component testing soft limit.

PRIORITY CLAIM

This application claims priority to and the benefit of U.S. ProvisionalApplication No. 62/403,568, entitled “Medical Fluid Therapy MachineIncluding Servicing Regime Therefore”, filed Oct. 3, 2016, the entirecontents of which are incorporated herein by reference and relied upon.

BACKGROUND

The present disclosure relates generally to devices, systems and methodsfor medical fluid delivery machines. More specifically, the presentdisclosure relates to the servicing of components used in medical fluiddelivery machines, such as renal failure therapy machines.

Regarding renal failure therapy machines, due to various causes, aperson's renal system can fail. Renal failure produces severalphysiological derangements. It is no longer possible to balance waterand minerals or to excrete daily metabolic load. Toxic end products ofnitrogen metabolism (urea, creatinine, uric acid, and others) canaccumulate in blood and tissue.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat normal functioning kidneys would otherwise remove. Dialysistreatment for replacement of kidney functions is critical to many peoplebecause the treatment is life saving.

One type of kidney failure therapy is Hemodialysis (“HD”), which ingeneral uses diffusion to remove waste products from a patient's blood.A diffusive gradient occurs across the semi-permeable dialyzer betweenthe blood and an electrolyte solution called dialysate or dialysis fluidto cause diffusion.

Hemofiltration (“HF”) is an alternative renal replacement therapy thatrelies on a convective transport of toxins from the patient's blood. HFis accomplished by adding substitution or replacement fluid to theextracorporeal circuit during treatment (typically ten to ninety litersof such fluid). The substitution fluid and the fluid accumulated by thepatient in between treatments is ultrafiltered over the course of the HFtreatment, providing a convective transport mechanism that isparticularly beneficial in removing middle and large molecules (inhemodialysis there is a small amount of waste removed along with thefluid gained between dialysis sessions, however, the solute drag fromthe removal of that ultrafiltrate is not enough to provide convectiveclearance).

Hemodiafiltration (“HDF”) is a treatment modality that combinesconvective and diffusive clearances. HDF uses dialysis fluid flowingthrough a dialyzer, similar to standard hemodialysis, to providediffusive clearance. In addition, substitution solution is provideddirectly to the extracorporeal circuit, providing convective clearance.

Most HD (HF, HDF) treatments occur in centers. A trend towards homehemodialysis (“HHD”) exists today in part because HHD can be performeddaily, offering therapeutic benefits over in-center hemodialysistreatments, which occur typically bi- or tri-weekly. Studies have shownthat frequent treatments remove more toxins and waste products than apatient receiving less frequent but perhaps longer treatments. A patientreceiving more frequent treatments does not experience as much of a downcycle as does an in-center patient, who has built-up two or three days'worth of toxins prior to a treatment. In certain areas, the closestdialysis center can be many miles from the patient's home causingdoor-to-door treatment time to consume a large portion of the day. HHDmay take place overnight or during the day while the patient relaxes,works or is otherwise productive.

Another type of kidney failure therapy is peritoneal dialysis, whichinfuses a dialysis solution, also called dialysis fluid, into apatient's peritoneal cavity via a catheter. The dialysis fluid contactsthe peritoneal membrane of the peritoneal cavity. Waste, toxins andexcess water pass from the patient's bloodstream, through the peritonealmembrane and into the dialysis fluid due to diffusion and osmosis, i.e.,an osmotic gradient occurs across the membrane. An osmotic agent indialysis provides the osmotic gradient. The used or spent dialysis fluidis drained from the patient, removing waste, toxins and excess waterfrom the patient. This cycle is repeated, e.g., multiple times.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), and tidal flow dialysis and continuous flow peritonealdialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, thepatient manually connects an implanted catheter to a drain to allow usedor spent dialysate fluid to drain from the peritoneal cavity. Thepatient then connects the catheter to a bag of fresh dialysis fluid toinfuse fresh dialysis fluid through the catheter and into the patient.The patient disconnects the catheter from the fresh dialysis fluid bagand allows the dialysis fluid to dwell within the peritoneal cavity,wherein the transfer of waste, toxins and excess water takes place.After a dwell period, the patient repeats the manual dialysis procedure,for example, four times per day, each treatment lasting about an hour.Manual peritoneal dialysis requires a significant amount of time andeffort from the patient, leaving ample room for improvement.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes drain, fill and dwell cycles. APD machines,however, perform the cycles automatically, typically while the patientsleeps. APD machines free patients from having to perform the treatmentcycles manually and from having to transport supplies during the day.APD machines connect fluidly to an implanted catheter, to a source orbag of fresh dialysis fluid and to a fluid drain. APD machines pumpfresh dialysis fluid from a dialysis fluid source, through the catheterand into the patient's peritoneal cavity. APD machines also allow forthe dialysis fluid to dwell within the cavity and for the transfer ofwaste, toxins and excess water to take place. The source may includemultiple sterile dialysis fluid bags.

APD machines pump used or spent dialysate from the peritoneal cavity,though the catheter, and to the drain. As with the manual process,several drain, fill and dwell cycles occur during dialysis. A “lastfill” occurs at the end of APD and remains in the peritoneal cavity ofthe patient until the next treatment.

Any of the above modalities performed by a machine include componentsthat wear out over time and need replacement. There is an inherentstruggle to not replace components too often, leading to excess cost andrepair time versus waiting for a complete component failure, after whichthe machine is down until the component is changed, leading to adisruption in a patient's treatment schedule, possible negative patientand doctor/clinician perception of the machine, and the need forservicing on an immediate basis.

U.S. Pat. No. 7,873,489, entitled, Dialysis Machine with ServicingIndicator”, discloses one servicing regime. The regime looks basicallyat two factors, namely, time that the component has been installedversus duration of time used. The regime sets three limits including anupper limit for duration of time used, a lower limit for time that thecomponent has been installed, and an upper limit for time that thecomponent has been installed. A component is not eligible forreplacement until it reaches its lower limit for time that the componenthas been installed, even if the upper limit for duration of time usedhas been met or exceeded. However, the component will be replaced whenit reaches its upper limit for time that the component has beeninstalled, regardless of its duration of time used.

While the servicing regime of U.S. Pat. No. 7,873,489 may be differentthan what was present in the prior art, it is believed that there isstill substantial room for improvement.

SUMMARY

The servicing regime described herein is applicable, for example, tofluid delivery for: plasmapherisis, hemodialysis (“HD”), hemofiltration(“HF”) hemodiafiltration (“HDF”), and continuous renal replacementtherapy (“CRRT”) treatments. The servicing regime described herein isalso applicable to peritoneal dialysis (“PD”) and to intravenous drugdelivery. These modalities may be referred to herein collectively orgenerally individually as medical fluid delivery.

Moreover, the servicing regime described herein may be used withclinical or home-based machines. For example, the systems may beemployed in in-center HD, HF or HDF machines, which run throughout theday. Alternatively, the systems may be used with home HD, HF or HDFmachines, which are operated at the patient's convenience. One such homesystem is described in U.S. Pat. No. 8,029,454 (“the '454 Patent”),issued Oct. 4, 2011, entitled “High Convection HomeHemodialysis/Hemofiltration And Sorbent System”, filed Nov. 4, 2004,assigned to the assignee of the present application. Other such homesystems are described in U.S. Pat. No. 8,393,690 (“the '690 Patent”),issued Mar. 12, 2013, entitled “Enclosure for a Portable HemodialysisSystem”, filed Aug. 27, 2008. The entire contents of each of the abovereferences are incorporated herein by reference and relied upon.

In an embodiment, a medical fluid delivery machine is provided thatincludes a medical fluid delivery chassis. The medical fluid deliverychassis houses components needed to deliver medical fluid, such as oneor more pump, plural valves, a heater if needed, online medical fluidgeneration equipment if needed and desired, plural sensors, such as anyone, or more, or all of pressure sensors, conductivity sensors,temperature sensors, air detectors, blood leak detectors, and the like,a user interface, and a control unit, which may employ one or moreprocessor and memory to control the above-described equipment. Themedical fluid delivery machine may also include one or more filter, suchas a dialyzer or hemofilter for cleansing blood and/or an ultrafilterfor purifying water, dialysis fluid, or other fluid.

Any of the operating components used in connection with the medicalfluid delivery machine may be subject to the servicing regime of thepresent disclosure. Certain ones of the components, such as a pumpactuator, valve actuator or heater, are built to last for a long time.Other components, such as a filter, are known to have a relatively shortlife compared with the long life components. Thus, each component of themachine may have its own service life expectancy or be classified intoone of different categories of life expectancy. To a certain extent, theservicing regime of the present disclosure is more applicable to shorterlife expectancy components and to longer life components nearing the endof their expected life. In any case, however, the servicing regime ofthe present disclosure may be applied to any operating component of themedical fluid delivery machine. “Operating component” may, but does nothave to, mean a component of the medical fluid delivery machine, or aperipheral thereto, which generates operating data or data that may betested to generate test data.

In one embodiment, the servicing regime analyzes self-test data overtime to analyze a component. For example, assume that the machineprovides an ultrafilter that purifies water, dialysis fluid or otherfluid. The machine may then run a self-test on the ultrafilter beforeeach treatment. The ultrafilter includes thin semi-permeable membranes,the walls of which have tiny pores that allow the liquid to pass and befiltered. If one of the membranes tears or if the pores begin to open,then the particulate that is intended to be filtered may pass throughthe tear or opened pores, such that the ultrafilter is not able to cleanthe liquid as well as it once could. One self-test is then to run apressure decay test on the membranes prior to treatment to see how muchthe membranes leak.

It is contemplated in the regime of the present disclosure to set twolimits for the pressure decay test, namely, a first replacement limitwhich if reached results in the ultrafilter having to be replaced. Asecond, soft, limit is also set, which tells the operator that thisparticular ultrafilter has begun to degrade and that it should bemonitored more closely, so that the ultrafilter may be replaced when itsleakage rate is close to but not at the replacement limit. There aremultiple advantages of the soft limit warning. First, the machine hasenjoyed most or even close to all of the useful life of the ultrafilter.Second, the replacement is made presumably at a convenient time for allparties involved and is done so on a “good idea” basis as opposed to a“must” basis. The machine is only down for the time needed to replacethe component. The patient and clinician/doctor do not have to waituntil a part arrives to run another treatment.

In another embodiment, the servicing regime analyzes componentperformance data over time, alternatively or additionally to theself-test data. As discussed above, one example self-test for anultrafilter is a pressure decay test that looks for leaks. In additionto leaks, ultrafilters may need to be replaced if they become clogged.As mentioned above, properly working ultrafilter membranes trapparticulate and allow purified liquid to pass. The trapped particulateforms a concentrated slurry with liquid that does not pass through themembranes. It is intended that the slurry be forced back to the inletside of the ultrafilter or to drain. However, the particulate instead oftraveling with the slurry may instead imbed itself into the walls of themembranes and begin to clog the ultrafilter.

It is accordingly contemplated to monitor the performance output of acomponent, such as the ultrafilter. For example, it is contemplated tomonitor the flowrate downstream of the ultrafilter. Replacement and softlimits are set again for the flowrate monitoring. After the soft limitis reached, the output flowrate performance of ultrafilter is monitoredclosely. The ultrafilter may then be replaced slightly before reachingthe replacement flowrate limit, thus extending ultrafilter life as muchas possible, while still maintaining a relatively high performancelevel.

A single component, such as the ultrafilter example, may accordinglyhave multiple criteria by which they are judged under the servicingregime of the present disclosure. Each criterion has its own soft limitthat is evaluated independently to determine when to change thecomponent.

The criterion may be evaluated for reasons in addition to the possiblereplacement of a component. For example, data may be collected frommultiple machines and evaluated to determine the most appropriate timeto order or build new ones of the components. For example, theultrafilter may be purchased from an outside company or be madein-house. But in either case, the component likely needs to be producedand ordered in a minimum quantity. If for example, the minimum order orproduction quantity for the ultrafilters is 100 pieces, there are only20 ultrafilters left in stock, and there are 30 ultrafilters in thefield that are at or below the soft limit, the system of the presentdisclosure may provide a prompt so that purchasing personnel may quicklyplace a new order for ultrafilters. In this manner, new components areordered only when needed but in time so that there is no shortage of thecomponent.

The servicing regime of the present disclosure may be implemented on amachine level, on an overarching platform system level that overseesmany machines, or a combination of same. Continuing with the ultrafilterexample, in one embodiment, each machine keeps track of the results ofthe pressure decay test, the downstream flowrate monitoring, thereplacement limit, and the soft limit. If a soft limit is reached, adisplay device of the machine may display an audio, visual oraudiovisual alert to the operator informing of the occurrence and/orprovide a servicing screen sharing same. The alert or servicing screenmay include a graph showing pressure decay data or downstream flowratedata in the days leading up to and including data from the day thattriggered the soft limit. The machine may be programmed to enter a“watch mode” after the soft limit is reached, in which the graph isupdated each time new data is generated, so that the user can see howthe ultrafilter is trending. Perhaps the data hovers around the softlimit, so that the ultrafilter may still be used. Or perhaps the datatrends down towards the replacement limit, indicating that theultrafilter needs to be replaced soon.

The machine may also calculate, using a current slope of the data linefrom the graph, or a curve formed mathematically from multiple datapoints, when the line would, assuming the slope or curve does notchange, intersect the replacement limit. Thus, along with the graph, themachine in the “watch mode” may display an estimated amount of days ortreatments until replacement is mandatory. The machine updates theestimate accordingly if the slope changes.

The “watch mode” output, including the graph and the number of days ortreatments until replacement, may be displayed additionally oralternatively at a remote computer, such as a clinician's computerand/or a service person's computer. As discussed in detail below, it iscontemplated to connect the machine via one or more server to a remoteclinician computer and/or a service person's computer. After eachtreatment, the machine sends data via the one or more server to adatabase accessible by the clinician computer and/or the serviceperson's computer. The “watch mode” data from multiple machines may beput into flagged folder. A service person, for example, may be taskedwith routinely accessing the flagged folder to view “watch mode” datafor multiple machines. The service person can then make a decision foreach “watch mode” scenario whether or not to schedule a componentreplacement.

It is contemplated to provide the medical fluid delivery machines of thepresent disclosure to multiple clinics and to include each of theclinics under the overall system of the present disclosure. The serviceperson, on the other hand, will typically support the manufacturer ofthe machines. The system is customizable then to enable each clinic todecide whether the clinic is to maintain its own machines or to insteadcontract the manufacturer's service personnel to maintain the machines.If the clinic maintains its own machines, the clinic may decide to letthe machines themselves display the “watch mode” as described herein.Alternatively, the clinic may access the flag files over the server(s)to analyze the “watch mode” data. If the clinic decides to contract themanufacturer's service personnel to maintain the machines, themanufacturer's service personnel monitor the flag files remotely overthe server(s) to access the “watch mode” data.

The example of the ultrafilter is used throughout this specificationbecause it is a component that clearly benefits from the servicingregime of the present disclosure. Ultrafilters are known to have limitedlives and are relatively expensive components. It is therefore desirableto obtain as much usage out of them as possible before replacement. Thedialyzer and hemofilter are other good examples. Dialyzers andhemofilters may be sterilized and packaged as part of a complete bloodset, which has to be replaced when the dialyzer leaks or deteriorates(clogs as is the case with the ultrafilter).

It should be appreciated that any component subjected to leak testing,such as pressure decay testing, may benefit from the servicing regime ofthe present disclosure. For instance, a treatment fluid pathway or bloodflow pathway, or parts thereof, may be pressure checked and placed in a“watch mode” or replaced if needed. Fluid valves and pumps may bepressure checked and placed in a “watch mode” or replaced if needed. Thefluid pumps may also be evaluated for downstream flowrate output. If themachine is driven pneumatically, its pneumatic solenoid valves may alsobe pressure checked and placed in a “watch mode” or replaced if needed.

It should also be appreciated that any sensing component whose output iscapable of being tested, e.g., by subjecting to a known pressure,temperature, or conductivity sample, may benefit from the servicingregime of the present disclosure. Other suitable components aredescribed herein.

In light of the disclosure herein and without limiting the disclosure inany way, in a first aspect of the present disclosure, which may becombined with any other aspect listed herein unless specified otherwise,a medical fluid delivery system includes: a medical fluid deliverymachine including at least one component producing associated outputdata; at least one component replacement limit for the at least onecomponent; and a computer programmed to store the at least one componentreplacement limit and to analyze the output data to provide anindication of how well the at least one component is performing relativeto its component replacement limit.

In a second aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the medicalfluid delivery machine includes a display device, the computer providedby a control unit of the medical fluid delivery machine, and wherein theindication is displayed by the display device of the medical fluiddelivery machine.

In a third aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the computeris a remote computer having a display device, the medical fluid deliverymachine in data communication with the remote computer via at least oneserver, and wherein the indication is displayed by the display device ofthe remote computer.

In a fourth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, theassociated output data includes a flowrate, and wherein at least one ofthe component replacement limits is a component replacement flowrate.

In a fifth aspect of the present disclosure, which may be combined withthe fourth aspect in combination with any other aspect listed hereinunless specified otherwise, the at least one component includes (i) afilter, the flowrate being a flowrate downstream of the filter, (ii) amedical fluid delivery pump, the flowrate being a flowrate downstream ofthe medical fluid delivery pump, or (iii) a disposable item, theflowrate being a flowrate downstream of the disposable item.

In a sixth aspect of the present disclosure, which may be combined withany other aspect listed herein unless specified otherwise, the systemincludes at least one component soft limit in addition to the at leastone component replacement limit stored by the computer, and wherein theindication of how well the at least one component is performing relativeto its component replacement limit includes whether the component isperforming between its soft limit and its component replacement limit.

In a seventh aspect of the present disclosure, which may be combinedwith the sixth aspect in combination with any other aspect listed hereinunless specified otherwise, the computer is programmed to generate atleast one component performance graph showing the at least one componentperforming relative to its soft limit and its component replacementlimit.

In an eighth aspect of the present disclosure, which may be combinedwith the sixth aspect in combination with any other aspect listed hereinunless specified otherwise, the computer is programmed to generate anestimate of when component performance will reach its replacement limitwhen the at least one component is performing between its soft limit andits component replacement limit.

In a ninth aspect of the present disclosure, which may be combined withthe sixth aspect in combination with any other aspect listed hereinunless specified otherwise, the computer is a remote computer, themedical fluid delivery machine in data communication with the remotecomputer via at least one server, and which includes a file provided bythe computer indicating each component performing between its soft limitand its component replacement limit.

In a tenth aspect of the present disclosure, which may be combined withthe sixth aspect in combination with any other aspect listed hereinunless specified otherwise, the computer is a remote computer, themedical fluid delivery machine in data communication with the remotecomputer via at least one server, and which includes a file provided bythe computer indicating each component of each machine performingbetween its soft limit and its component replacement limit.

In an eleventh aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thecomputer receives the output data associated with the component aftereach treatment performed by the medical fluid delivery device.

In a twelfth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, amedical fluid delivery system includes: a medical fluid delivery machineincluding at least one component subjected to a test to produce testdata; at least one component replacement limit for the at least onecomponent; and a computer programmed to store the at least one componentreplacement limit and to analyze the test data to provide an indicationof how well the at least one component is testing relative to itscomponent replacement limit.

In a thirteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, the atleast one component includes a sensor for the medical fluid deliverymachine, the test analyzing an output from the sensor.

In a fourteenth aspect of the present disclosure, which may be combinedwith the thirteenth aspect in combination with any other aspect listedherein unless specified otherwise, the sensor is a pressure sensor,conductivity sensor or a temperature sensor.

In a fifteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, themedical fluid delivery machine includes an air pressure source, apressure sensor, and wherein the test is a pressure decay test in whichthe at least one component is subjected to air pressure via the source,which is sensed by the pressure sensor.

In a sixteenth aspect of the present disclosure, which may be combinedwith the fifteenth aspect in combination with any other aspect listedherein unless specified otherwise, the at least one component includes(i) a filter including a filtering membrane, the pressure decay testtesting the filtering membrane, (ii) a fluid delivery component, thepressure decay test testing the fluid delivery component for a leak,(iii) a disposable component, the pressure decay test testing thedisposable component for a leak or (iv) a fluid line, the pressure decaytest testing the fluid line for a leak.

In a seventeenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, themedical fluid delivery machine includes a display device, the computerprovided by a control unit of the medical fluid delivery machine, andwherein the indication is displayed by the display device of the medicalfluid delivery machine.

In an eighteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thecomputer is a remote computer having a display device, the medical fluiddelivery machine in data communication with the remote computer via atleast one server, and wherein the indication is displayed by the displaydevice of the remote computer.

In a nineteenth aspect of the present disclosure, which may be combinedwith any other aspect listed herein unless specified otherwise, thesystem includes at least one component soft limit in addition to the atleast one component replacement limit stored by the computer, andwherein the indication of how well the at least one component is testingrelative to its component replacement limit includes whether componenttesting performance is between its soft limit and its componentreplacement limit.

In a twentieth aspect of the present disclosure, which may be combinedwith the nineteenth aspect in combination with any other aspect listedherein unless specified otherwise, the computer is programmed togenerate at least one testing performance graph showing the at least onecomponent testing performance relative to its soft limit and itscomponent replacement limit.

In a twenty-first aspect of the present disclosure, which may becombined with the nineteenth aspect in combination with any other aspectlisted herein unless specified otherwise, the computer is programmed togenerate an estimate of when component testing performance will reachits replacement limit when the at least one component testingperformance is between its soft limit and its component replacementlimit.

In a twenty-third aspect of the present disclosure, which may becombined with the nineteenth aspect in combination with any other aspectlisted herein unless specified otherwise, the computer is a remotecomputer, the medical fluid delivery machine in data communication withthe remote computer via at least one server, and which includes a fileprovided by the computer indicating each component having testingperformance between its soft limit and its component replacement limit.

In a twenty-fourth aspect of the present disclosure, which may becombined with the nineteenth aspect in combination with any other aspectlisted herein unless specified otherwise, the computer is a remotecomputer, the medical fluid delivery machine in data communication withthe remote computer via at least one server, and which includes a fileprovided by the computer indicating each component of each machinehaving testing performance between its soft limit and its componentreplacement limit.

In a twenty-fifth aspect of the present disclosure, which may becombined with any other aspect listed herein unless specified otherwise,the computer receives the test data associated with the component aftereach treatment performed by the medical fluid delivery device.

In a twenty-sixth aspect of the present disclosure, which may becombined with any other aspect listed herein unless specified otherwise,a medical fluid delivery system includes: a medical fluid deliverymachine including at least one component yielding associated output dataand associated test data; at least one component output replacementlimit for the at least one component; at least one component testingreplacement limit for the at least one component; and a computerprogrammed to store the at least one component output replacement limitand the at least one component testing replacement limit and to analyzethe output data and the test data to provide a first indication of howwell the at least one component is performing relative to its componentoutput replacement limit and a second indication of how well the atleast one component is testing relative its the component testingreplacement limit.

In a twenty-seventh aspect of the present disclosure, which may becombined with any other aspect listed herein unless specified otherwise,a medical fluid delivery system includes: a medical fluid deliverymachine including a component yielding at least one of associated outputdata or associated test data; at least one of a (i) component outputreplacement limit and a component output soft limit for the component or(ii) a component testing replacement limit or a component testing softlimit for the component; and a computer programmed to store at least oneof (i) or (ii), and for (i) analyze the output data to provide a firstindication of how well the component is performing relative to thecomponent output replacement limit and the component output soft limit,and for (ii) analyze the test data to provide a second indication of howwell the at least one component is testing relative to the componenttesting replacement limit and the component testing soft limit.

In a twenty-eighth aspect of the present disclosure, which may becombined with any other aspect listed herein unless specified otherwise,a medical fluid delivery system includes: a medical fluid deliverymachine operating with a disposable set over multiple treatments to mixfor each treatment at least one concentrate with water made suitable fora desired medical fluid treatment to form a medical fluid; a sensorconfigured to test the accuracy of the medical fluid mixed by themedical fluid delivery machine, the sensor producing an output enablingmixing accuracy to be determined; and a computer programmed to determinemixing accuracies from the mixing accuracy outputs produced by thesensor and determine whether the disposable set needs to be replaced.

In a twenty-ninth aspect of the present disclosure, which may becombined with the twenty-eighth aspect in combination with any otheraspect listed herein unless specified otherwise, the computer isprogrammed to use a rolling average to determine whether the disposableset needs to be replaced.

In a thirtieth aspect of the present disclosure, which may be combinedwith the twenty-eighth aspect in combination with any other aspectlisted herein unless specified otherwise, the computer is a computer forthe medical fluid delivery machine or a computer located remote from themedical fluid delivery machine.

In a thirty-first aspect of the present disclosure, which may becombined with the twenty-eighth aspect in combination with any otheraspect listed herein unless specified otherwise, the computer isprogrammed to determine at least one of whether the disposable set needsto be replaced (i) now or (ii) for a treatment in the future.

In a thirty-second aspect of the present disclosure, any of thestructure and functionality disclosed in connection with FIGS. 1 to 8may be combined with any of the other structure and functionalitydisclosed in connection with FIGS. 1 to 8.

In light of the present disclosure and the above aspects, it istherefore an advantage of the present disclosure to provide an improvedmedical fluid delivery device.

It is another advantage of the present disclosure to provide an improvedservicing regime for medical fluid delivery devices.

It is a further advantage of the present disclosure to efficientlyreplace medical fluid delivery machine components.

It is still another advantage of the present disclosure to help preventdowntime due to having to wait for a component replacement.

It is still a further advantage of the present disclosure to provide anefficient way for ordering and stocking medical fluid delivery machinecomponents.

It is yet another advantage of the present disclosure to provide asystem that is flexible to the servicing needs of different medicalfluid delivery machine users.

It is yet a further advantage of the present disclosure to provide aservicing regime that is applicable to different types of componentsused in a medical fluid delivery machine.

The advantages discussed herein may be found in one, or some, andperhaps not all of the embodiments disclosed herein. Additional featuresand advantages are described herein, and will be apparent from, thefollowing Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic illustration of one embodiment of a medical fluiddelivery machine of the present disclosure.

FIG. 2 is a perspective view illustrating a blood set for use with oneembodiment of the medical fluid delivery machine of FIG. 1.

FIG. 3 is a schematic view illustrating one embodiment for a system thatincorporates the medical fluid delivery machines of the presentdisclosure, so that data may be obtained from such machines.

FIG. 4 is a perspective view of one embodiment of a peritoneal dialysissystem including a cycler and disposable set therefore, which may beimplemented in the system of FIG. 3 and use any of the servicing regimeembodiments discussed herein.

FIG. 5 is a plot illustrating one embodiment for a servicing regime ofthe present disclosure.

FIG. 6 illustrates a watch mode screen for a single machine showingwhich of its components have output metrics at or below a soft limit ofthe present disclosure.

FIG. 7 illustrates a flag or watch mode screen for multiple machinesshowing which machines have at least one component with output metricsat or below a soft limit of the present disclosure.

FIG. 8 is a screen shot showing charted data for a machine componentover multiple replacement cycles.

DETAILED DESCRIPTION

The examples described herein are applicable to any medical fluiddelivery system that delivers a medical fluid, such as blood, dialysisfluid, substitution fluid or and intravenous drug (“IV”). The examplesare particularly well suited for kidney failure therapies, such as allforms of hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration(“HDF”), continuous renal replacement therapies (“CRRT”) and peritonealdialysis (“PD”), referred to herein collectively or generallyindividually as renal failure therapy. Moreover, the machines and theservicing regimes described herein may be used in clinical or homesettings. For example, a machine operating with the servicing regime ofthe present disclosure may be employed in an in-center HD machine, whichruns virtually continuously throughout the day. Alternatively, theservicing regime of the present disclosure may be used in a home HDmachine, which can for example be run at night while the patient issleeping.

Referring now to FIG. 1, an example of an HD flow schematic for amedical fluid delivery system 10 operating with the servicing regime ofthe present disclosure is illustrated. Because the HD system of FIG. 1is relatively complicated, FIG. 1 and its discussion also providesupport for any of the renal failure therapy modalities discussed aboveand for an IV or drug delivery machine. Generally, system 10 is shownhaving a very simplified version of a dialysis fluid or process fluiddelivery circuit. The blood circuit is also simplified but not to thedegree that the dialysis fluid circuit is simplified. It should beappreciated that the circuits have been simplified to make thedescription of the present disclosure easier, and that the systems ifimplemented would have additional structure and functionality, such asis found in the publications incorporated by reference above.

System 10 of FIG. 1 includes a blood circuit 20. Blood circuit 20 pullsblood from and returns blood to a patient 12. Blood is pulled frompatient 12 via an arterial line 14, and is returned to the patient via avenous line 16. Arterial line 14 includes an arterial line connector 14a that connects to an arterial needle 14 b, which is in blood drawcommunication with patient 12. Venous line 16 includes a venous lineconnector 16 a that connects to a venous needle 16 b, which is in bloodreturn communication with the patient. Arterial and venous lines 14 and16 also include line clamps 18 a and 18 v, which can be spring-loaded,fail-safe mechanical pinch clamps. Line clamps 18 a and 18 v are closedautomatically in an emergency situation in one embodiment.

Arterial and venous lines 14 and 16 also include air or bubble detectors22 a and 22 v, respectively, which can be ultrasonic air detectors. Airor bubble detectors 22 a and 22 v look for air in the arterial andvenous lines 14 and 16, respectively. If air is detected by one of airdetectors 22 a and 22 v, system 10 closes line clamps 18 a and 18 v,pauses the blood and dialysis fluid pumps, and provides instructions tothe patient to clear the air so that treatment can resume.

A blood pump 30 is located in arterial line 14 in the illustratedembodiment. In the illustrated embodiment, blood pump 30 includes afirst blood pump pod 30 a and a second blood pump pod 30 b. Blood pumppod 30 a operates with an inlet valve 32 i and an outlet valve 32 o.Blood pump pod 30 b operates with an inlet valve 34 i and an outletvalve 34 o. In an embodiment, blood pump pods 30 a and 30 b are eachblood receptacles that include a hard outer shell, e.g., spherical, witha flexible diaphragm located within the shell, forming a diaphragm pump.One side of each diaphragm receives blood, while the other side of eachdiaphragm is operated by negative and positive air pressure. Blood pump30 is alternatively a peristaltic pump operating with the arterial line14 tube.

A heparin vial 24 and heparin pump 26 are located between blood pump 30and blood filter 40 (e.g., dialyzer) in the illustrated embodiment.Heparin pump 26 may be a pneumatic pump or a syringe pump (e.g., steppermotor driven syringe pump). Supplying heparin upstream of blood filter40 helps to prevent clotting of the filter's membranes.

A primary control processor (“ACPU”) or control unit 50 includes one ormore processor and memory. Control unit 50 receives air detectionsignals from air detectors 22 a and 22 v (and other sensors of system10, such as temperature sensors, blood leak detectors, conductivitysensors, pressure sensors, and access disconnection transducers 102,104), and controls components such as line clamps 18 a and 18 v, bloodpump 30, heparin pump 26, and the dialysis fluid pumps. Blood exitingblood filter 40 via venous line 16 flows through an airtrap 28. Airtrap28 removes air from the blood before the dialyzed blood is returned topatient 12 via venous line 16.

With the hemodialysis version of system 10 of FIG. 1, dialysis fluid ordialysate is pumped along the outside of the membranes of blood filter40, while blood is pumped through the insides of the blood filtermembranes. Dialysis fluid or dialysate is prepared beginning with thepurification of water via a water purification unit 60. One suitablewater purification unit is set forth in U.S. Patent Publication No.2011/0197971, entitled, “Water Purification System and Method”, filedApr. 25, 2011, the entire contents of which are incorporated herein byreference and relied upon. In one embodiment, water purification unitincludes filters and other structures to purify tap water (e.g., removepathogens and ions such as chlorine), so that the water is in oneimplementation below 0.03 endotoxin units/ml (“EU/ml”) and below 0.1colony forming units/ml (“CFU/ml”). Water purification unit 60 may beprovided in a housing separate from the housing or chassis of thehemodialysis machine, which includes blood circuit 20 and a dialysisfluid circuit 70.

Dialysis fluid circuit 70 is again highly simplified in FIG. 1 to easeillustration. Dialysis fluid circuit 70 in actuality may include all ofthe relevant structure and functionality set forth in the publicationsincorporated by reference above. Certain features of dialysis fluidcircuit 70 are illustrated in FIG. 1. In the illustrated embodiment,dialysis fluid circuit 70 includes a to-blood filter dialysis fluid pump64. Pump 64 is in one embodiment configured the same as blood pump 30.Pump 64, like pump 30, includes a pair of pump pods 66 each having inletvalves 68 i and outlet valves 68 o, which again may be sphericallyconfigured. The two pump pods, like with blood pump 30, are operatedalternatingly so that one pump pod is filling with HD dialysis fluid,while the other pump pod is expelling HD dialysis fluid.

Pump 64 is a to-blood filter dialysis fluid pump. There is another dualpod pump chamber 96 operating with valves 98 i and 98 o located in drainline 82 to push used dialysis fluid to drain. There is a third pod pump(not illustrated) for pumping pump purified water through a bicarbonatecartridge 72. There is a fourth pod pump (not illustrated) used to pumpacid from acid container 74 into mixing line 62. The third and fourthpumps, the concentrate pumps, may be single pod pumps because continuouspumping is not as important in mixing line 62 due to a bufferingdialysis fluid tank (not illustrated) between mixing line 62 andto-blood filter dialysis fluid pump 64 in one embodiment.

A fifth pod pump (not illustrated) provided in drain line 82 is used toremove a known amount of ultrafiltration (“UF”) when an HD therapy isprovided. System 10 keeps track of the UF pump to control and know howmuch ultrafiltrate has been removed from the patient. System 10 ensuresthat the necessary amount of ultrafiltrate is removed from the patientby the end of treatment.

Each of the above-described pumps may alternatively be a peristalticpump operating with a pumping tube. If so, the system valves may stillbe actuated pneumatically according to the features of the presentdisclosure.

In one embodiment, purified water from water purification unit 60 ispumped along mixing line 62 though bicarbonate cartridge 72. Acid fromcontainer 74 is pumped along mixing line 62 into the bicarbonated waterflowing from bicarbonate cartridge 72 to form an electrolytically andphysiologically compatible dialysis fluid solution. The pumps andtemperature-compensated conductivity sensors used to properly mix thepurified water with the bicarbonate and acid are not illustrated but aredisclosed in detail in the publications incorporated by reference above.

FIG. 1 also illustrates that dialysis fluid is pumped along a freshdialysis fluid line 76, through a heater 78 and an ultrafilter 80,before reaching blood filter 40, after which used dialysis fluid ispumped to drain via drain line 82. Heater 78 heats the dialysis fluid tobody temperature or about 37° C. Ultrafilter 80 further cleans andpurifies the dialysis fluid before reaching blood filter 40, filteringbugs or contaminants introduced for example via bicarbonate cartridge 72or acid container 74 from the dialysis fluid.

Dialysis fluid circuit 70 also includes a sample port 84 in theillustrated embodiment. Dialysis fluid circuit 70 will further include ablood leak detector (not illustrated but used to detect if a bloodfilter 40 fiber is torn) and other components that are not illustrated,such as balance chambers, plural dialysis fluid valves, and a dialysisfluid holding tank, all illustrated and described in detail in thepublications incorporated by reference above.

In the illustrated embodiment, hemodialysis system 10 is an online,pass-through system that pumps dialysis fluid through blood filter onetime and then pumps the used dialysis fluid to drain. Both blood circuit20 and dialysis fluid circuit 70 may be hot water disinfected after eachtreatment, such that blood circuit 20 and dialysis fluid circuit 70 maybe reused. In one implementation, blood circuit 20 including bloodfilter 40 is hot water disinfected and reused daily for about one month,while dialysis fluid circuit 70 is hot water disinfected and reused forabout six months.

In alternative embodiments, for CRRT for example, multiple bags ofsterilized dialysis fluid or infusate are ganged together and used oneafter another. In such a case, the emptied supply bags can serve asdrain or spent fluid bags.

The machine 90 of system 10 includes an enclosure as indicated by thedashed line of FIG. 1. The enclosure of machine 90 varies depending uponthe type of treatment, whether the treatment is in-center or a hometreatment, and whether the dialysis fluid/infusate supply is abatch-type (e.g., bagged) or on-line.

FIG. 2 illustrates that machine 90 of system 10 of FIG. 1 may operatewith a blood set 100. Blood set 100 includes arterial line 14, venousline 16, heparin vial 24, heparin pump 26/blood pump 30 and blood filter40 (e.g., dialyzer). An airtrap 28 may be located in venous line 16 toremove air from the blood before being returned to patient 12. Airdetectors 22 a and 22 v contact arterial and venous lines 14 and 16,respectively, for operation.

In FIGS. 1 and 2, any of pumps 26, 30 (30 a and 30 b), 64, 96 (and otherpumps not illustrated) and any of the valves, such as valves 32 i, 32 o,34 i, 34 o, 68 i, 68 o, 98 i, and 98 o may be pneumatically actuated. Inan embodiment, each of the pumps and valves has a fluid side and an airside, separated by a flexible membrane. Negative pneumatic pressure maybe applied to the air side of the membrane to draw fluid into a pumpchamber or to open a valve (or the pump or valve could be opened byventing positive closing pressure to atmosphere and allowing fluidpressure to open). Positive pneumatic pressure is applied to the airside of the membrane to expel fluid from a pump chamber or to close avalve.

Referring now to FIG. 3, system 10 is illustrated operating within alarger platform system 110. System 110 incorporates many medical fluiddelivery machines 90 and thus many associated medical fluid deliverymachine systems 10. Machines 90 of platform system 110 may be of a sametype (e.g., all HD machines) or be of different types (e.g., a mix ofHD, PD, CRRT, medical delivery).

While a single medical fluid delivery machine 90 is illustrated ascommunicating with a connectivity server 118, system 110 oversees theoperation of a plurality of medical fluid delivery machines, of the sametype or of different types listed above. For example, there may be Mnumber of hemodialysis machines 90, N number of hemofiltration machines90, O number of CRRT machines 90, P number of peritoneal dialysismachines 90, Q number of home drug delivery machines 90, and R number ofnutritional home therapy machines 90 connected to server 118 andoperating with system 110. The numbers M through R may be the same ordifferent numbers, and may be zero, one, or more than one. In FIG. 3,medical fluid delivery machine 90 is illustrated as a home therapymachine 90. However, as discussed below, medical fluid delivery machine90 does not have to be used at home (indicated by dashed lines) and mayinstead be used in a hospital or clinic.

Home therapy machine 90 may receive at its front end purified water froma water treatment device 60 as discussed above. Water treatment device60 connects to home therapy machine 90 via an Ethernet cable in anembodiment. Home therapy machines 90 of system 110 in the illustratedembodiment operate with other devices besides water treatment device 60,such as a blood pressure monitor 104, a weigh scale, e.g., wirelessweigh scale 106, and a user interface such as a wireless tablet userinterface 122. Home therapy machine 90 connects to server 118 wirelesslyin one embodiment via a modem 102. Each of these components may (butdoes not have to be) located within the patient's home, as demarcated bythe dashed lines in FIG. 3. Any one, or more or all of components 60,104, 106 and 122 may communicate wired or wirelessly with home therapymachine 90. Wireless communication may be via Bluetooth™ WiFi™ Zigbee®,Z-Wave®, wireless Universal Serial Bus (“USB”), infrared, or any othersuitable wireless communication technology. Alternatively, any one, ormore or all of components 60, 104, 106 and 122 may communicate with hometherapy machine 90 via wired communication.

Connectivity server 118 communicates with much of home medical devicesystem 110 via a home medical device system hub 120. System hub 120enables data and information concerning each home therapy machine 90 andits peripherals to travel back and forth via connectivity server 118between machines 90 and the other clients connected to server 118. Inthe illustrated embodiment, system hub 120 is connected to a serviceportal 130, an enterprise resource planning system 140, a web portal150, a business intelligence portal 160, a HIPAA compliant database 124,a product development team 128 and electronic medical records databases126 a to 126 n.

Electronic medical records (“EMR”) databases 126 a to 126 n storeelectronic information concerning patients. System hub 120 may send thedata collected from log files of machine 90 to hospital or clinicdatabases 126 a to 126 n to merge or supplement that patient's medicalrecords. Databases 126 a to 126 n may contain patient-specific treatmentand prescription data and therefore access to such databases may behighly restricted. Enterprise resource planning system 140 obtains andcompiles data generated via the patient and clinician website access,such as complaints, billing information and life cycle managementinformation. Web portal 150 enables patients and clinics 152 a to 152 ntreating the patients to access a website publicly available for usersof system 110. Business intelligence portal 160 collects data fromsystem hub 120 and provides data to marketing 162, research anddevelopment 164, and quality/pharmacovigilance 166.

It should be appreciated that the systems, methods and proceduresdescribed herein may be implemented using one or more computer programsor components. The programs of components may be provided as a series ofcomputer instructions on any conventional computer-readable medium,including random access memory (“RAM”), read only memory (“ROM”), flashmemory, magnetic or optical disks, optical memory, or other storagemedia. The instructions may be configured to be executed by a processor,which when executing the series of computer instructions performs orfacilitates the performance of all or part of the disclosed methods andprocedures.

In one embodiment, home therapy machine 90 performs a home treatment,such as home hemodialysis on a patient at the patient's home and thenreports the results of that treatment to clinicians, doctors and nurseswho are responsible for managing the health and well-being of thatpatient. The results of the treatment may include data from therapymachine and data from its peripherals including water treatment device60. Water treatment device 60 data may include, for example, totalvolume of water delivered, quality of water delivered (e.g., chlorinecontent), how many different times water treatment device 60 deliveredwater to therapy machine 90 over the course of a treatment (this datacould be monitored by device 60 or machine 90), average flowrate of thewater delivered, any alarms or alerts that water treatment device 60experienced over a treatment, and/or an amount of time or number ofcycles performed over the course of a treatment, e.g., for componentreplacement information.

Home therapy machines 90 in an embodiment write log files using, e.g., aLinux™ operating system. The log files document pertinent home therapymachine 90 data, including peripheral device data. The log files mayinclude any one or more of Extensible Markup Language (“XML”),comma-separated values (“CSV”) or text files. The log files are placedinto a file server box of the software of home therapy machine 90. It isalso contemplated to store data at a peripheral device, e.g., watertreatment device 60, which is not sent to machine 90. Such data mayotherwise be obtained via the wired or wireless connection to theperipheral device or downloaded through other data connections orstorage media. For example, a service person can access additional datavia a laptop connected to water treatment device 60 or wireless weighscale 106, e.g., via an Ethernet connection. Or, the additional data maybe retrieved remotely from the peripheral devices, with home therapymachine 90 serving as the data transfer liaison between the peripheraldevice and authorized clients of system 110.

In one embodiment, home therapy machine 90, e.g., via the Internet, usesa connectivity service to transfer data between modem 102 and system hub120. Here, a dedicated line may be provided at each patient's home forconnecting the home therapy machine 90 to the connectivity server 118via modem 102. Home therapy machine 90 in one embodiment accesses theInternet using a separate, e.g., 3G, 4G or 5G, modem 102. Modem 102 mayuse an Internet Service Provider (“ISP”), such as Vodafone™. In oneimplementation, a connectivity agent 114 developed by a connectivityservice provider (e.g., provider of connectivity server 118) isinstalled onto the home therapy machine 90 and run on ACPU 50 of themachine. One suitable connectivity service is provided by Axeda™, whichprovides a secure managed connection 116 between medical devices and theconnectivity server 118.

Connectivity agent 114 allows the home therapy machine 90 to connect toconnectivity server 118 and transfer data to and from the connectivityserver 118. The connectivity service operating via agent 114 and server118 ensures that the connection with machine 90 is secure, ensures thatthe data correctly passes through machine 90's firewalls, checks whetherthere has been a data or system crash, and ensures that connectivityserver 118 is communicating with the correct home therapy machine 90.

In one embodiment, home therapy machine 90 may only connect toconnectivity server 118 when connectivity agent 114 is turned on oractivated. During treatment and post-treatment disinfection, whilemachine 90 and its peripherals are functioning, connectivity agent 114is turned off if one embodiment, which prevents home therapy machine 90from communicating with any entity and sending or receiving data duringtreatment and disinfection or when machine 90 is live or running. Whenhome therapy machine 90 is idle, e.g., after treatment andpost-disinfection is complete, ACPU 112 turns connectivity agent 114 onin one embodiment. In an embodiment, connectivity agent 114 is off onlyduring treatment (including pretreatment). After treatment, connectivityagent 114 retrieves the log files from the home therapy machine 90 andtransfers data to the connectivity server 118 using the connectivityservice. The connectivity service routes data packets to their properdestination but in one embodiment does not modify, access, or encryptthe data.

In system 110 of FIG. 3, the connectivity service via connectivityserver 118 may communicate data to various places via a system hub 120,such as a service portal 130, clinics or hospitals 126 a to 126 n, and aweb portal 150. Connectivity server 118 allows service personnel 132 ato 132 n and/or clinicians to track and retrieve various assets acrossthe network, such as appropriate home therapy machines 90 and 3G, 4G or5G modem 102, and their associated information, including machine ormodem serial numbers. Connectivity server 118 may also be used toreceive and provide firmware upgrades, approved by a director of servicepersonnel 134 and obtained remotely via service portal 130, toauthorized home therapy machines 90 and associated peripherals, such aswater treatment devices 60.

The servicing regimes described herein may be performed in multipleplaces when viewing FIG. 3. When the medical fluid delivery machines 90are home therapy machines, the servicing regimes or the presentdisclosure may be provided at the computers of service personnel 132 ato 132 n or at the computers of doctors or clinicians 126 a to 126 n. Apatient at home is generally associated with a hospital or clinic 126 ato 126 n. That hospital or clinic may decide to service its ownmachines, in which case the servicing regimes of the present disclosureare provided at the computers of doctors or clinicians 126 a to 126 n.Or, that hospital or clinic may decide to have the machine manufacturerassociated with overall system 110 service the machines, in which casethe servicing regimes of the present disclosure are provided at thecomputers of service personnel 132 a to 132 n (but may still be viewableat the computers of doctors or clinicians 126 a to 126 n).

In another embodiment, medical fluid delivery machines 90 are notprovided in the patient's home but are instead provided in hospitals orclinics 126 a to 126 n. Here, the hospital or clinic has three choices,namely, (i) the hospital or clinic contracts machine manufacturerassociated with overall system 110 to service the machines, such thatthe servicing regimes of the present disclosure are provided at thecomputers of service personnel 132 a to 132, (ii) hospital or clinicservices its own machines and provides the servicing regimes of thepresent disclosure at the computers of doctors or clinicians 126 a to126 n, or (iii) hospital or clinic services its own machines andprovides the servicing regimes of the present disclosure at machines 90themselves. In option (iii), machines 90 may, but do not have to, havethe networking described herein, e.g., using connectivity server 118 orsystem hub 120.

Dialyzer 40 is an example of a component that when used with certainhemodialysis systems is a single component and when used with otherhemodialysis systems is a multi-treatment component. For systemsrequiring multiple uses of dialyzer 40, the dialyzer may be subject toclearance and/or integrity tests as discussed above. Similarly, FIG. 4illustrates one embodiment for a peritoneal dialysis system 210, whichmay operate to use a disposable set only once or over multipletreatments. Peritoneal dialysis system 210 includes a peritonealdialysis machine or cycler 212, which operates a disposable set 220.Disposable set 220 includes a disposable pumping cassette 222, which mayinclude a hard plastic middle section 224 sealed on both surfaces by aflexible plastic sheet, diaphragm or membrane 226. Hard plastic middlesection 224 defines pump and valve chambers, rigid fluid flow paths andports for mating with tubing 228 of disposable set 220 and tubing 232associated with solution bags 230. Tubing 228 in one embodiment runs tothe patient, a drain and a heater bag 234 of disposable set 220.

In use, heater bag 234 is placed on a heating tray 214 of cycler 212.When not in use, as illustrated in FIG. 4, a user interface 216 ofcycler 212 folds down into heating tray 214 and is covered by a lid ofcycler 212. In use, disposable pumping cassette 222 is loaded against apump and valve actuation area 218 of cycler 212. A door including aninflatable bladder and push plate 240 is closed onto and pressurized topress disposable pumping cassette 222 into operation with pump and valveactuation area 218 of cycler 212. In an embodiment, the fluid pumps andvalves of disposable pumping cassette 222 are actuated pneumatically.Alternatively, the fluid pumps and valves of disposable pumping cassette222 are actuated electomechanically, e.g., via peristaltic pumping.

Disposable set 220 is in one embodiment a single use or treatment itemand is discarded after the single use. In another embodiment, disposableset 220 is reused multiple times. For example, disposable set 220 may bedisinfected chemically and/or via radiation, e.g., via ultravioletlight, between uses. When reused, the soft and hard limits of thepresent disclosure may be employed. For example, disposable pumpingcassette 222, tubing 228, 232, solution bags 230 and heater bag 234 mayeach be subjected to one or more common or individualized integrity testafter each treatment. A soft limit could be triggered for example whenmeasured integrity air pressure drops a certain amount within a certaintime period. The disposable set 220 may still be reused after soft limitis reached, but the patient or user is put on notice that the disposableset will need to be changed soon. In another embodiment, the patient oruser is told to change the disposable set when the soft limit isreached.

In another example, pumping performance is measured before, duringand/or after treatment. Here, cycler 212 may expect that a pump chamberor valve chamber of disposable pumping cassette 222 should reach itsend-of-stroke position within a certain period of time. Cycler 212 maysense an end-of-stroke position by looking for a pressure spike thatoccurs when membrane 226 bottoms-out against a pump or valve chamberwall of hard plastic middle section 224. As membrane 226 becomes usedmore and more over multiple treatments, it may tend to wear out, suchthat a longer period of time is needed for membrane 226 to bottom-out atthe end-of-stroke position to be seen for the same applied operatingpressure. Here, a soft limit may be set to trigger when membrane 226performance has degraded by, for example, 20 percent. At such time, thepatient or user may be told to change disposable set 220 or to beprepared to change disposable set 220 soon. The end-of-strokeperformance measurement may be done using positive pressure to bottommembrane 226 out into hard plastic middle section 224, using negativepressure to bottom membrane 226 out outwardly against pump and valveinterface 218, or both.

In an electromechanical example, e.g., when a peristaltic pump is used,the performance metric may be output pressure. It may be expected thatat a certain a certain pressure output is provided at a certainrotational pump speed of the peristaltic pump. When pressure outputlessens due to the peristaltic pump tube wearing out over multipletreatments, a soft limit, e.g., twenty percent pressure loss, may betriggered. At such time, the patient or user may be told to change thedisposable set or to be prepared to change the disposable set soon. Theperistaltic pump performance measurement may be done using positivepressure output of the electromechanical pump, using negative pressureinput to the electromechanical pump, or both.

In another example, the ability of a valve of disposable pumpingcassette 222 to stay closed when under positive pressure may beevaluate. Here, a valve of cassette 222 when primed with fluid may beclosed pneumatically, e.g., under a positive pressure of five psig. Theclosed valve is then subjected to fluid pressure from within via anactuation of a pump chamber in fluid communication with the valve,starting e.g., at three psig and ramping up. It is expected that thevalve will open when the pumping pressure exceeds the valve holdingpressure of five psig. When this happens a measurable pressure drop willoccur at the pump chamber as fluid may now travel through the valve. Butif the measured pressure drop indicating the valve opening occurs beforethe valve closing pressure of five psig is reached, it may indicate animproperly seated valve or a worn out valve membrane 226. When valveholding pressure lessens, e.g., to twenty percent of the valve closingpressure for any reason, a soft limit may be triggered. At such time,the patient or user may be told to change disposable set 220 or to beprepared to change the disposable set 220 soon.

In a further example, the ability of pneumatically actuated orelectromechanically driven fluid pumps to mix a solution properly ismonitored. One or more conductivity sensor may be used, for example, toverify that cycler 212 (or hemodialysis machine 90) has mixed one ormore concentrate in the correct proportion(s) with water purified to besuitable for whatever treatment is being performed. Here, the soft andhard limit system and methodology of the present disclosure may (butdoes not have to) look for weighted trends or trends over multiple daysand/or treatments to determine if a soft limit has been reached. Forexample, if a moving average three day or treatment trend falls below acertain accuracy percentage of commanded conductivity, e.g., at or belowninety-five percent accurate, then a soft limit is reached. At suchtime, the patient or user may be told to change the disposable set or tobe prepared to change the disposable set soon. The weighted trend allowsfor one or more mixing conductivity outcomes falling beneath thespecified accuracy level to occur without triggering a soft limit. In athree day average trend, where the three days produce mixingconductivity accuracies of 96%, 96% and 94%, for example, the average of95.3% remains above the accuracy limit of 95%, such that a soft limit isnot triggered. But if the next day also yields a mixing conductivityaccuracy of 94%, for example, then the current three day results become,96%, 94% and 94% and produce an average of 94.7%, which does trigger asoft limit of the present disclosure. Moving averages allow foranomalies to occur in situations where anomalies typically occur, e.g.,in mixing situations in which the mixture may not be perfectlyhomogenous, so as to not overreact and thereby prolong the life of thedisposable item.

It should be appreciated that each of the examples discussed inconnection with peritoneal dialysis system 210 of FIG. 4 is equallyapplicable to any blood cleaning modality discussed herein, e.g., oneemploying medical fluid delivery machine 90 and/or blood set 100. FIG. 2for example shows a pneumatically operated blood set 100, which may besubject to pneumatic integrity and performance tests, pumping outputtests, and/or mixing accuracy tests as just described.

Referring now to FIG. 5, a servicing regime as illustrated may beimplemented at the computers of service personnel 132 a to 132 (FIG. 3),at the computers of doctors or clinicians 126 a to 126 n (FIG. 3),and/or on machines 90 (FIG. 3) and/or 212 (FIG. 4) themselves. FIG. 5illustrates an embodiment of the servicing regime of the presentdisclosure. Component use count is provided along the x-axis, while aperformance metric for the component is provided along the y-axis. Inthe illustrated example, better performance is indicated by a largernumber along the y-axis, e.g., fluid flowrate through an ultrafilter 80(FIG. 1).

As illustrated in FIG. 5, in a first component replacement scenario (1),the component, e.g., ultrafilter 80, is replaced after a certain numberof treatments or after a certain number of hours in use. This scenariois disadvantageous because to make sure that the component is not usedafter failure, the treatment number limit or hours of use limit has tobe set low with a safety factor to account variabilities in each of thecomponents analyzed under this scenario.

As illustrated in FIG. 5, in a second component replacement scenario(2), the component is replaced reactively after it fails. This scenariois also disadvantageous because replacement is now a necessity beforeanother treatment can be run, which may take the machine offline while anew component is retrieved. Also, the component may fail during atreatment, potentially creating a safety issue. Further, the componentfailure may leave a negative impression with the patient, doctor and/orclinician concerning machine 90 or cycler 212.

As illustrated in FIG. 5, in the servicing regime of the presentdisclosure, a soft limit is set at some safety factor above the hardlimit, which indicates a component failure performance along the y-axis.The soft limit as illustrated will generally allow for a greater numberof treatments or hours of operation than the conservative time or usebased limit. Even if the component is replaced at the soft limit, thereis likely a prolonging of component life and a decrease in component andservicing cost over time relative to the conservative limit.

It is however not required to replace the component when the soft limitis reached. The soft limit instead puts relevant people on notice thatcomponent replacement is immanent. The soft limit is one way accordingto the present disclosure to provide an indication of how well thecomponent is performing relative to the component replacement limit.

There are at least two ways to configure the x-axis of FIG. 5, namely,to make the units represent component (i) use count (e.g., number oftreatments) or (ii) component use time (e.g., hours of service actuallyperformed). There are also at least two general ways in which theperformance metric along the y-axis may be measured. In a first way, theperformance metric of a machine component is measured by measuring anoutput of the component. In one example, ultrafilter 80 may be evaluatedby measuring an output flowrate of purified fluid from the ultrafilterat a set inlet fluid pressure to the ultrafilter. In a second way, theperformance metric of a machine component is measured by testing thecomponent. In one example, ultrafilter 80 may be evaluated via pressuretesting, e.g., a pressure decay test. Both the output and testingmetrics evaluate the porous hollow fiber membranes of ultrafilter 80.The flowrate metric checks to see if the porous hollow fiber membranesare clogged or blocked, while the pressure test metric checks to see ifthe porous hollow fiber membranes are leaking, e.g., if there is a tearin one or more of the membranes.

It is therefore contemplated to track two or more performance metrics,e.g., via database or via a graph such as that of FIG. 5, for the samecomponent, e.g., ultrafilter 80. An algorithm is then programmed tosignal when either of the performance metrics reaches the respectivesoft limit or the respective hard limit. That is, the first metric tofail, or begin to fail, controls the replacement of the component.

Both performance metric analyses, component output and componenttesting, may be performed one or more time for each treatment usingmedical fluid delivery machine 90 or cycler 212. For example, thepressure testing of ultrafilter 80 may be performed before eachtreatment to make sure ultrafilter 80 is not leaking. The output ofultrafilter 80 is the flowrate of fresh dialysis fluid along line 76(FIG. 1) from the ultrafilter 80 to dialyzer 40, e.g., at a set pumpingpressure provided by fresh dialysis fluid pump 64. The average flowratefor a treatment may be determined by dividing a total amount of dialysisfluid delivered to dialyzer 40 divided by the total time that dialysisfluid pump 64 is running during treatment (e.g., total treatment timeless downtime for alarms, etc.). The generation of treatment performancemetric data is important to monitoring the soft limits of the presentdisclosure and to track how well the component is performing relative tothe component replacement limit. Per-treatment performance data may beuploaded to desired places of overall system 110 as discussed aboveand/or maintained at machine 90 or cycler 212.

The following is a non-exclusive list of components from FIGS. 1 to 4having outputs that may be monitored as a performance metric accordingto FIG. 5: (i) ultrafilter of water purification unit 60 having purifiedwater flowrate output, (ii) pump of water purification unit 60 havingpurified water flowrate output, (iii) pre-filter pack of waterpurification unit 60 having chlorine removal capability output, (iv)blood pump 30 having blood flowrate output, (v) dialyzer 40 having bloodflowrate output, (vi) fresh water and concentrate pumps (not illustratedin FIG. 1) having fresh water and concentrate flowrate outputsrespectively, (vii) fresh dialysis fluid pump 66 having fresh dialysisfluid flowrate output, (viii) ultrafilter 80 having fresh dialysis fluidflowrate output, (ix) dialyzer 40 having used dialysis fluid flowrateoutput, (x) used dialysis fluid pump 96 having used dialysis fluidflowrate output, (xi) ultrafiltrate pump (not illustrated in FIG. 1)having ultrafiltrate flowrate output, and (xii) output metrics for bloodset 100 and disposable set 220.

It should be appreciated from the above list that certain outputs, suchas fresh dialysis fluid flowrate, are associated with multiplecomponents, e.g., fresh dialysis fluid pump 66 and ultrafilter 80. Asdiscussed in detail below, it is contemplated to develop and maintaincharacteristic performance curves for different components of medicalfluid delivery machine 90 or cycler 212. The characteristic performancecurves for two different components associated with the same output maybe different enough such that the actual performance curve dictateswhich component is failing. For example, the characteristic outputflowrate from ultrafilter 80 may slope over time as in FIG. 5, while thecharacteristic output flowrate from fresh dialysis fluid pump 66 mayshow a sharp drop off in performance. If the actual fresh dialysis fluidflowrate deterioration matches one of the characteristic fresh dialysisfluid flowrate deteriorations, then the corresponding component may beassumed to be the culprit. Alternatively, a service person may prepareto replace either component, e.g., dialysis fluid pump 66 or ultrafilter80, whichever is needed when servicing is performed.

The following is a non-exclusive list of components from FIGS. 1 to 4having outputs that may be tested as a performance metric according toFIG. 5: (i) pressure test of ultrafilter of water purification unit 60,(ii) test of chlorine sensor of water purification unit 60 using knowndechlorinated water and/or water of known amount of chlorine, (iii) atest of any or all conductivity sensors in dialysis fluid circuit 70 ofFIG. 1 using fluid of zero conductivity and/or fluid of knownconductivity, (iv) a test of any or all pressure sensors (e.g.,pneumatic pressure sensors) associated with blood circuit 20 anddialysis fluid circuit 70 of FIG. 1 using test fluid (e.g., air) atknown pressure, (v) leak test (e.g., pressure decay test) of any or allvalves (e.g., pneumatic valves) associated with blood circuit 20 anddialysis fluid circuit 70 of FIG. 1, (vi) a pressure test (e.g.,pressure decay) of any fluid line section associated with blood circuit20 and dialysis fluid circuit 70 of FIG. 1, wherein the section includesa fluid pump chamber in between to fluid valves defining the segment andenabling the pump chamber to fluidly pressurize the line segment, (vii)a pressure test (e.g., pressure decay) of ultrafilter 80, (viii) a fiberbundle test known to those of skill in the art to assess the clearanceability of the membranes of dialyzer 40, (ix) a conductivity or sodiumspike test (e.g., upstream and downstream of dialyzer 40) known to thoseof skill in the art to assess the clearance ability of the membranes ofdialyzer 40, (x) a test of air detectors 22 a and 22 v via passing aliquid known to have entrained air through the sensors, and (xi) testsperformed on blood set 100 and disposable set 220.

In one embodiment, when the performance of a component reaches a softlimit as illustrated in FIG. 5, the component is placed in a “watchmode”. Watch mode components may be communicated to necessaryindividuals in a variety of ways. FIG. 6 illustrates a watch mode screen242, which may be provided on wireless tablet user interface 122 (FIG.3) of machine 90 (or screen 216 of cycler 212) at clinics 126 a to 126 nthat would rather a service person or clinician have access to theinformation at the machine itself rather than remotely at a computer.Watch mode screen 242 is specific to its machine 90 or cycler 212 in oneembodiment. Watch mode screen 242 lists each component of machine 90 orcycler 212 whose performance data or test data has deteriorated to thesoft limit illustrated in FIG. 5. For each component, the example watchmode screen 242 of FIG. 6 provides: (i) the name of the component, (ii)the location of the component in machine 90 or cycler 212 (e.g.,specifying which of multiple ones of the same component), (iii) productordering or replacement number, (iv) a projected number of uses or hoursbefore the replacement limit, (v) a projected replacement limit date,and (vi) a link to a chart or graph of the performance data or test data(e.g., also showing projected replacement limit date) like FIG. 5.

In the illustrated embodiment, components are ordered by replacementurgency, in which components having the greatest urgency are listed atthe top. Screen 242 may be provided by machine 90 (or screen 216 ofcycler 212) as a flag or alert to prompt the clinician or service personto review the soft limit data. Alternatively, screen 242 is provided aspart of a service mode of machine 90 (or screen 216 of cycler 212),which the clinician or service person is instructed to check routinely.

The projected replacement limit number of uses or hours is provided inone embodiment by determining the slope of the line from the last twodata points and extending the line from the last data point at thedetermined slope for future intervals along the x-axis of the chart, anddetermining where the extended line hits the horizontal replacementlimit line (FIG. 5), and from there estimating how many additionaltreatments or service hours may be available before component failureoccurs. The estimated additional treatments or service hours may beconverted additionally into a projected future date of mandatorycomponent replacement if it is known how many treatments or servicehours are performed per day, taking into account weekends, holidays, offdays, etc.

Using a linear slope over the last two data points may be found to betoo reactionary. It is accordingly contemplated to alternatively fit acurve mathematically to all relevant data points. For example, asillustrated in FIG. 5, a curve could be fitted to all performance metricdata points that are a predetermined percentage above the soft limitoutput (output of 6), for example, beginning at the output of 8(y-axis), which occurs at ten or eleven uses (x-axis). Once the actualoutput hits the soft limit output (at nineteen component uses), thecomponent is added to watch mode screen 242 and a predicted number ofadditional component uses until failure is provided. The slope of theline l₁ in FIG. 5 between ten and nineteen uses predicts abouttwenty-seven total uses before failure. However, once on the watch list,the mathematical curve taking to account the performance metric outputat twenty-one and twenty-two uses adjusts the prediction to failure(output of 4) via line l₂ to be twenty-four total uses. At twenty-twouses, the service person or other authorized personnel therefore knowsto change the component quickly.

Referring now to FIG. 7, an example watch mode screen 244 shown at thecomputers of service personnel 132 a to 132 n and/or at the computers ofhospitals or clinics 126 a to 126 n is illustrated. Service personnel132 a to 132 n and hospitals or clinics 126 a to 126 n monitor multiplemachines 90 or cyclers 212. Watch mode screen 244 accordingly lists eachmachine under the control of service personnel 132 a to 132 n orhospitals or clinics 126 a to 126 n having at least one component withperformance or test data at or below the soft limit. For each listing,example watch mode screen 244 provides: (i) location (e.g., facility,room at facility, or patient's home), (ii) machine identity/type, (iii)number of components at soft limit for that machine, (iv) shortestnumber of uses/hours to failure, and (v) earliest date of failure.Again, the watch mode screen 244 listings may be ordered by replacementurgency in which machines 90 or cyclers 212 with components having thegreatest urgency are listed at the top.

FIG. 7 illustrates different types of machines under one clinic orhospital, e.g., hemodailysis machines (“HD”), peritoneal dialysismachines (“PD”), infusion or large volume pumps (“LVP”), and CRRTmachines. Note that for the location column, a clinic site may be listedfor in-center machines 90 or cyclers 212, while a patient's name (e.g.,J. Doe, P. Shent) may be listed for a home machine 90 or cycler 212.

Watch made screen 244 may be provided as a flag or alert file at thecomputer of clinic 126 a to 126 n or service personnel 132 as a prompt.Alternatively, the clinician, service person or other authorized personmay be tasked with checking watch made screen 244 routinely. When theservice person, clinician or other authorized person selects one of themachine listings on watch mode screen 244, a screen the same as orsimilar to watch mode screen 242 discussed above at FIG. 6 appears onclinician computer 126 a to 126 n or service person computer 132,showing each component of the selected machine with performance or testdata at or below the soft limit, including all the information providedby screen 242 discussed above. The service person, clinician or otherauthorized person proceeds accordingly.

It is another feature of the present disclosure to analyze and trackperformance or test data over multiple cycles in an attempt to observetrends in the data. For example, FIG. 6 shows that watch mode screen 242for a particular machine 90 (or screen 216 of cycler 212) may providetrend buttons for components that are replaced frequently, such as anULTRAFILTER TRENDS button 246, a DIALYZER TRENDS button 248, a PRESSURESENSOR TRENDS button 250, and a PNEUMATIC VALVE TRENDS button 252.Selecting any of the trends buttons, e.g., ULTRAFILTER TRENDS button 246brings the user to a dedicated trends screen, such as ultrafilter trendsscreen 254 of FIG. 8, which may be displayed on any of machine userinterface or tablet 122, screen 216 of cycler 212, the computer of ahospital or clinic 126, or the computer of a service person 132.

Ultrafilter trends screen 254 illustrates four different consecutiveinstances in which ultrafilter 80 (FIG. 1) was replaced (vertical dashedline) on the same machine 90 or cycler 212 and in one embodiment for asame patient. For the same date, an upper plot shows flowrate output,while a lower plot shows driving pressure. A service person, clinicianor other user viewing ultrafilter trends screen 254 of FIG. 8 gets asense of (i) how long on average that ultrafilter 80 lasts for aparticular machine treating a particular patient, (ii) what the flowratecurve looks like just before ultrafilter 80 replacement, and (iii) whatthe driving pressure curve looks like just before ultrafilter 80replacement. Viewing the plots at the furthest right of screen 254, fromthe dates Feb. 6, 2016 to Feb. 18, 2016, the user can see that all threeindicators, namely, duration in service, flowrate output, and drivepressure required, indicate that the present ultrafilter 80 is currentlyperforming well and that replacement is not immanent. It is contemplatedthat similar conclusions may be made viewing performance trends for adialyzer via DIALYZER TRENDS button 248, a pressure sensor via PRESSURESENSOR TRENDS button 250, and a pneumatic valve via PNEUMATIC VALVETRENDS button 252 illustrated in FIG. 6.

FIG. 6 provides trends buttons for a single machine 90 or cycler 212. Ifmachine 90 or cycler 212 is provided at home, then the trends buttonswill also be for a single patient. It is therefore expresslycontemplated for system 10 and the servicing regimes of the presentdisclosure to develop trends for specific patients, including trackingwhich components the patient is consuming most frequently and how often.Comparing one patient's trends to another may shed light on why certaincomponents wear out faster for certain patients. Such analysis may leadto a determination that certain types of treatment or treatmentprescriptions, e.g., more frequent treatments, longer treatments, highertemperature treatments, etc., lead to more frequent replacement ofcertain machine components.

If machine 90 or cycler 212 is provided at a clinic 126 a to 126 n, thenthe trends buttons will likely be for multiple patients. Analyzing datafor a machine treating multiple patients tends to take individualpatients out of the equation. This data is good for system 10 to comparetwo different makes of the same machine, e.g., different manufacturersor older versus newer machines. Such analysis may lead to adetermination that certain types makes or brands of machine 90 or cycler212 lead to more frequent replacement of certain machine components.

FIG. 7 illustrates buttons that allow for the user to see combined datafrom like machines (HD, PD, LVP, CRRT) across a whole clinic, acrossmultiple clinics, or across an entire manufacturer's platform. AnULTRAFILTERS AVERAGED button 256 may for example provide averagedreplacement durations and split such data by ultrafilter brand ifdifferent ones exist and/or by any other desired feature, such asaverage operating pressure, dialysis fluid temperature, etc. Similarinformation may be provided for dialyzers 40 via a DIALYZERS AVERAGEDbutton 258 and may additionally include analysis in light of bloodflowrate. Averaging may also be performed and displayed for otherdesirable components, such as pressure sensors, pneumatic valves, andpump and valve diaphragms.

FIG. 7 also illustrates a REORDER NOW button 260, which shows the userwhich components should be reordered promptly and why. Suppose lead timeand minimum order quantity for ultrafilter 80 are four weeks and 100pieces, respectively, and that there are twenty ultrafilters currentlyin stock. Assume also that the service regime of the present disclosureshows on average that three ultrafilters 80 are replaced each week, butthat the present soft limit list shows that six ultrafilters 80 arecurrently at their soft limit, with five or less days until projectedmandatory replacement. The estimate for the next four weeks (one leadtime period) is therefore that six (soft limit for first week)+three(average for the second week)+three (average for the third week)+three(average for the fourth week) or fifteen ultrafilters 80 will beconsumed. The service regime may be programmed to alert the user via theREORDER NOW button 260 whenever the four week (one lead time period)projection shows five or fewer ultrafilters 80 remaining in stock.Pressing REORDER NOW button 260 thereby informs the user to reorderultrafilter 80 and provides reasoning therefore in one embodiment.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A medical fluid delivery systemcomprising: a medical fluid delivery machine including at least onecomponent, an air pressure source, and a pressure sensor, wherein the atleast one component is subjected to a pressure decay test in which theat least one component is pressurized via air pressure from the airpressure source for producing associated output data provided by atleast one of the pressure sensor or the at least one component, theoutput data being related to an operation or a performance of the atleast one component for a medical fluid delivery treatment; at least onecomponent replacement limit for the at least one component; at least onecomponent soft limit for the at least one component, the at least onecomponent soft limit indicative of a degradation in the operation or theperformance of the at least one component; and a computer programmed tostore the at least one component replacement limit and the at least onecomponent soft limit, analyze the output data in relation to the atleast one component replacement limit and the at least one componentsoft limit, and provide an indication of how well the at least onecomponent is performing relative to the at least one componentreplacement limit, the indication including whether the at least onecomponent is operating between the at least one component soft limit andthe at least one component replacement limit.
 2. The medical fluiddelivery system of claim 1, wherein the medical fluid delivery machineincludes a display device, the computer provided by a control unit ofthe medical fluid delivery machine, and wherein the indication isdisplayed by the display device of the medical fluid delivery machine.3. The medical fluid delivery system of claim 1, wherein the computer isa remote computer having a display device, the medical fluid deliverymachine in data communication with the remote computer via at least oneserver, and wherein the indication is displayed by the display device ofthe remote computer.
 4. The medical fluid delivery system of claim 1,wherein the indication-includes a number of uses or treatments remainingfor the at least one component before reaching the at least onecomponent replacement limit.
 5. The medical fluid delivery system ofclaim 1, wherein the computer is programmed to generate at least onecomponent performance graph showing the at least one componentperforming relative to the at least one component soft limit and the atleast one component replacement limit.
 6. The medical fluid deliverysystem of claim 1, wherein the computer is programmed to generate anestimate of when component performance will reach the at least onereplacement limit when the at least one component is performing betweenthe at least one component soft limit and the at least one componentreplacement limit.
 7. The medical fluid delivery system of claim 1,wherein the computer is a remote computer, the medical fluid deliverymachine is in data communication with the remote computer via at leastone server, and the at least one component includes two or morecomponents, and which includes a file provided by the computerindicating which of the two or more components is performing between theat least one component soft limit and the at least one componentreplacement limit.
 8. The medical fluid delivery system of claim 1,wherein the computer is a remote computer, the medical fluid deliverymachine is in data communication with the remote computer via at leastone server, and the at least one component includes two or morecomponents, and which includes a file provided by the computerindicating which of the two or more components of the medical fluiddelivery machine and other medical fluid delivery machines areperforming between the at least one component soft limit and the atleast one component replacement limit.
 9. The medical fluid deliverysystem of claim 1, wherein the computer receives the output dataassociated with the at least one component after each treatmentperformed by the medical fluid delivery device.
 10. The medical fluiddelivery system of claim 1, wherein the associated output data includesa flowrate, and wherein at least one of the component replacement limitsis a component replacement flowrate.
 11. The medical fluid deliverysystem of claim 10, wherein the at least one component includes (i) afilter, the flowrate being a flowrate downstream of the filter, (ii) amedical fluid delivery pump, the flowrate being a flowrate downstream ofthe medical fluid delivery pump, or (iii) a disposable item, theflowrate being a flowrate downstream of the disposable item.
 12. Amedical fluid delivery system comprising: a medical fluid deliverymachine including at least one component, an air pressure source, and apressure sensor, wherein the at least one component is subjected to apressure decay test in which the at least one component is pressurizedvia air pressure from the air pressure source to produce test dataprovided by at least one of the pressure sensor or the at least onecomponent; at least one component replacement limit for the at least onecomponent; and a computer programmed to store the at least one componentreplacement limit and to analyze the test data to provide an indicationof how well the at least one component is testing relative to the atleast one component replacement limit.
 13. The medical fluid deliverysystem of claim 12, wherein the at least one component includes (i) afilter including a filtering membrane, the pressure decay test testingthe filtering membrane, (ii) a fluid delivery component, the pressuredecay test testing the fluid delivery component for a leak, (iii) adisposable component, the pressure decay test testing the disposablecomponent for a leak, or (iv) a fluid line, the pressure decay testtesting the fluid line for a leak.
 14. The medical fluid delivery systemof claim 12, wherein the medical fluid delivery machine includes adisplay device, the computer provided by a control unit of the medicalfluid delivery machine, and wherein the indication is displayed by thedisplay device of the medical fluid delivery machine.
 15. The medicalfluid delivery system of claim 12, wherein the computer is a remotecomputer having a display device, the medical fluid delivery machine indata communication with the remote computer via at least one server, andwherein the indication is displayed by the display device of the remotecomputer.
 16. The medical fluid delivery system of claim 12, wherein thecomputer receives the test data associated with the at least onecomponent after each treatment performed by the medical fluid deliverydevice.
 17. The medical fluid delivery system of claim 12, wherein theat least one component includes a sensor for the medical fluid deliverymachine, the test analyzing an output from the sensor.
 18. The medicalfluid delivery system of claim 17, wherein the sensor is the pressuresensor, a conductivity sensor, or a temperature sensor.
 19. The medicalfluid delivery system of claim 12, which includes at least one componentsoft limit in addition to the at least one component replacement limitstored by the computer, the at least one component soft limit indicativeof a degradation in an operation or a performance of the at least onecomponent, wherein the indication of how well the at least one componentis testing relative to the at least one component replacement limitincludes whether component testing performance is between the at leastone component soft limit and the at least one component replacementlimit.
 20. The medical fluid delivery system of claim 19, wherein thecomputer is a remote computer, the medical fluid delivery machine indata communication with the remote computer via at least one server, andwhich includes a file provided by the computer indicating which of theat least one component of the medical fluid delivery machine and othermedical fluid delivery machines are performing between the at least onecomponent soft limit and the at least one component replacement limit.21. The medical fluid delivery system of claim 19, wherein the computeris programmed to generate at least one testing performance graph showingthe at least one component testing performance relative to the at leastone component soft limit and the at least one component replacementlimit.
 22. The medical fluid delivery system of claim 19, wherein thecomputer is programmed to generate an estimate of when the componenttesting performance will reach the at least one replacement limit whenthe component testing performance is between the at least one componentsoft limit and its component replacement limit.
 23. The medical fluiddelivery system of claim 19, wherein the computer is a remote computer,the medical fluid delivery machine in data communication with the remotecomputer via at least one server, and which includes a file provided bythe computer indicating which of the at least one component isperforming between the at least one component soft limit and the atleast one component replacement limit.
 24. A medical fluid deliverysystem comprising: a medical fluid delivery machine including at leastone component, an air pressure source, and a pressure sensor, whereinthe at least one component is subjected to a pressure decay test inwhich the at least one component is pressurized via air pressure fromthe air pressure source to produce associated output data and associatedtest data that are related to an operation or a performance of the atleast one component, the associated output data and the associated testdata being produced by at least one of the pressure sensor or the atleast one component; at least one component output replacement limit forthe at least one component; at least one component soft limit for the atleast one component, the at least one component soft limit indicative ofa degradation in the operation or the performance of the at least onecomponent; at least one component testing replacement limit for the atleast one component; and a computer programmed to store the at least onecomponent output replacement limit, the at least one component softlimit, and the at least one component testing replacement limit, analyzethe output data in relation to the at least one component outputreplacement limit and the at least one component soft limit, analyze thetest data in relation to the at least one component testing replacementlimit, provide a first indication of how well the at least one componentis performing relative to the at least one component output replacementlimit, the first indication including whether the at least one componentis operating between the at least one component soft limit and the atleast one component output replacement limit, and provide a secondindication of how well the at least one component is testing relative tothe at least one component testing replacement limit.
 25. A medicalfluid delivery system comprising: a medical fluid delivery machineincluding a component, an air pressure source, and a pressure sensor,wherein the component is subjected to a pressure decay test in which thecomponent is pressurized via air pressure from the air pressure sourceto produce at least one of associated output data or associated testdata that are related to an operation or a performance of the component,the at least one of associated output data or associated test data beingproduced by at least one of the pressure sensor or the component; atleast one of (i) a component output replacement limit and a componentoutput soft limit for the component or (ii) a component testingreplacement limit or a component testing soft limit for the component;and a computer programmed to store at least one of (i) or (ii), if (i)is stored, analyze the output data to provide a first indication of howwell the component is performing relative to the component outputreplacement limit and the component output soft limit, and if (ii) isstored, analyze the test data to provide a second indication of how wellthe component is testing relative to the component testing replacementlimit and the component testing soft limit.